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PBP (Panitumumab beyond Progression)

ABSTRACT: Interventions: Second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor Primary outcome(s): 6-month progression-free survival (PFS) rate Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

DISEASE(S): Colorectal Cancer

PROVIDER: 2614860 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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NPY methylated ctDNA is a promising biomarker for treatment response monitoring in metastatic colorectal cancer

Project description:Abstract Purpose Analysis of methylation markers in liquid biopsies is a promising technique for the follow-up of metastatic colorectal cancer (mCRC) patients, since they can be used in all patients, regardless of their mutational status. Therefore, we studied the value of NPY methylation analysis in circulating tumor DNA (ctDNA) for accurate response monitoring in mCRC patients in the PANIB trial. Experimental design The PANIB trial was a randomized phase two trial designed to compare FOLFOX plus panitumumab and FOLFOX plus bevacizumab in patients with RAS wild-type unresectable mCRC. The results of sequential liquid biopsies were correlated with results of imaging. Results Forty patients were included from six Belgian hospitals. Analysis of the liquid biopsies revealed that higher baseline levels of methylated ctDNA was associated with a significantly shorter overall survival (HR, 1.015; 95% CI 1.005 -1.025 and p=0.002). Furthermore, thirty-seven patients provided at least two liquid biopsies. Thirty-one of them showed a decrease in the methylation ratio after the start of therapy, which corresponded with stable disease or response on imaging at the first evaluation. When comparing the panitumumab and bevacizumab arm, significantly higher objective response and early tumor shrinkage rates were observed in the panitumumab arm (p=0.048 and p=0.015, respectively). However, due to a small study population, the trial was underpowered to detect a significant difference in survival. Conclusions The results of this study confirm that baseline methylated ctDNA is a prognostic marker and indicate that NPY methylation is a promising marker for response monitoring in patients with mCRC

| EGAS00001006820 | EGA

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